Camurus and Indivior Set to Significantly Sway the Opioid Abuse Treatment Market

Transcription

1 REPORT David Franklin, Camurus and Indivior Set to Significantly Sway the Opioid Abuse Treatment Market Companies: ALKS, DEPO, LON:INDV, STO:CAMX, STO:ORX, TTNP March 2, 2017 Report Type: Initial Coverage Previously Covered Full Report Update Rating: 3.5/5 Research Question: How will the new long-acting buprenorphine options and changing government rules affect the opioid abuse treatment market? Summary of Findings Weekly and monthly injectable buprenorphine treatments that could significantly affect the medication-assisted treatment (MAT) market for opioid abuse disorder include CAM2038 by Braeburn Pharmaceuticals Inc. and Camurus AB (STO:CAMX) as well as Indivior plc s (LON:INDV) RBP Both products, yet to be approved by the FDA, have performed well in trials and could be available by early Sources were highly interested and even excited about these products, which can prevent diversion, are suitable for a wide patient profile, offer higher dosages, are injections rather than implants, are expected to be competitively priced, and should be more appealing to third-party payers. This is a continuation and advancement of the trends found in Blueshift Research s April 8, 2016, report, which found that longacting implantable and injectable buprenorphine was expected to become an important tool and gain a significant foothold in treating opioid-addicted patients over time. Titan Pharmaceuticals Inc. s (TTNP) and Braeburn s recently approved Probuphine, a six-month implantable buprenorphine, is not expected to be widely adopted. Sources cited the small number of stable recovery patients that would be eligible users, the product s low dosage and high cost ($5,000 to $6,000 per sixmonth treatment plus physician visits), and the minor procedure required for implantation and removal. The U.S. Department of Health and Human Services rule changes to expand the opioid abuse disorder treatment cap from 100 to 275 patients for physicians as well as the inclusion of nurse practitioners and physician assistants as buprenorphine prescribers are in their very early stages. Sources expect these changes to slowly and minimally expand the number of patients in treatment in the next three to five years. The exception will be in urban areas in which physicians are at or near the 100-patient cap, have treatment waiting lists, and can rapidly add patients following certification for the expanded load. Sources expressed concern regarding the future of the Affordable Care Act and the related effects on opioid addiction treatment numbers. When Medicaid was expanded under the ACA, treatment populations increased. Silo Summaries 1) Physicians and Medical Professionals The addition of new patients seeking MAT is expected to rise very slowly during the next three to five years as physicians gradually expand their patient counts and as NPs and PAs gain certification to prescribe buprenorphine. The exception will be physicians in urban areas who are at or near the 100-patient cap and have waiting lists. Probuphine is not expected to have a significant effect on the MAT market; rather, it will serve a small segment of the population that is stable in their recovery program and require a very low dose (8 mg or less) of buprenorphine. CAM2038 and RBP-6000 are expected to have more success than Probuphine because they are weekly or monthly injections, offer higher doses of buprenorphine, and require that patients return to their physicians for counseling and to be tested for compliance. 2) Prescription Opioid Sales Channel Two of these three sources expect the treatment rule changes to allow more access to MAT and, as a result, sales will increase. One of the two said a 10% to 20% increase over time is possible. The remaining source said the expansion of the patient cap was a positive, but expects the rule changes to minimally affect treatment numbers because most family physicians are already at or near capacity with their regular patients. All three expect Probuphine to have minimal uptake because of its limited patient population, its high cost and its required surgical procedure. Two sources think CAM2038, the weekly or monthly injectable buprenorphine, will be successful; one even said it could gain 30% to 40% share. 3) Industry Specialists These five sources think the MAT rule changes will slowly increase the number of opioid abuse patients receiving treatment. One source reported an initial jump in patient number, followed by a slowdown. A second source said the effect will be minimal while a third said the growth will not be a big as expected by the medical community. Two sources said a change may be required in the medical practice business model, with additional and dedicated physicians and support personnel needed to exclusively treat opioid abuse patients. The use of Probuphine is expected to be limited as the eligible patient population is small, the dosage is low, the cost is prohibitive, and the procedure requires minor surgery. Long-acting injectable buprenorphine could be promising. Given the high number of opioid overdoses, CAM2038 should be fast-tracked through the FDA. 1

2 HHS Rule Changes Effects on Patient Number Probuphine Adoption Interest in Weekand Month-Long Injectables Physicians and Medical Professionals Up slightly Limited Prescription Opioid Sales Channel Up over time Limited Industry Specialists Up slightly and over time Limited Background Blueshift Research s April 8, 2016, report found that long-acting implantable and injectable buprenorphine was expected to become an important tool and gain a significant foothold in treating opioid-addicted patients over time. All 15 sources acknowledged the clinical value of treating stable patients with long-acting buprenorphine. Sources expectations for market penetration varied, but two (a physician and an addiction treatment professional) expected long-acting buprenorphine to claim 20% to 25% share. Weekly and monthly treatments likely would be more widely used than the six-month dosage. In the United States, opioid addiction has been described as an epidemic, and overdose deaths, including from prescription opioids and heroin, have more than quadrupled since Overdoses killed more than 28,000 people in 2014; over half of those deaths were from prescription opioids. Ninety-one deaths occur every day as a result of opioid overdose. The HHS has expanded the maximum number of patients being treated for opioid dependency by a physician from 100 to 275 (commonly called the patient cap), and now allows nurse practitioners and physician assistants to complete the required training and be able to prescribe buprenorphine for up to 30 patients, beginning sometime this year. New buprenorphine delivery systems are becoming available that are implantable or injectable and last a week, a month or six months, in the case of Titan s and Braeburn s recently approved Probuphine. The drugs are expected to lower the potential for misuse and the effects of physical dependency to opioids and eliminate daily visits to methadone clinics. Two post-phase 3 drugs that could hit the market later this year or in early 2018 are Indivior s RBP-6000, a monthly injection, and Braeburn s and Camurus s CAM2038, a weekly or monthly injection. In its third-quarter earnings call, Titan management indicated that since the FDA approval of Probuphine, Braeburn has trained 2,400 healthcare professionals in 50 states and Puerto Rico on how to insert and remove the ProNeura implant, and has obtained third-party coverage from large and regional insurance companies as well as under Medicare, Medicaid and the Department of Veterans Affairs. Adoption of Probuphine reportedly has been slowed by time-consuming paperwork. Braeburn is devoting resources to streamline the process. Current Research Blueshift Research assessed how the new long-acting buprenorphine treatment options and changing government rules are affecting the opioid abuse treatment market. We employed our pattern mining approach to establish five independent silos, comprising 21 primary sources (including seven repeat sources) and five secondary sources focused on the opioid abuse treatment market. Interviews were conducted Feb : 1) Physicians and medical professionals (10) 2) Prescription opioid sales channel (3) 3) Industry specialists (5) 4) Third-party payers (3) 5) Secondary sources (5) 2

3 Next Steps Blueshift Research will continue to research how changes in patient caps affect the opioid abuse treatment market. We will monitor patient numbers as well as the related effects on the opioid epidemic and the companies that service the treatment communities. We also will assess adoption of Probuphine and the launch of CAM2038 and RBP Silos 1) Physicians and Medical Professionals The addition of new patients seeking MAT is expected to rise very slowly during the next three to five years as physicians gradually expand their patient counts and as NPs and PAs gain certification to prescribe buprenorphine. The exception will be physicians in urban areas who are at or near the 100-patient cap and have waiting lists. Probuphine is not expected to have a significant effect on the MAT market; rather, it will serve a small segment of the population that is stable in their recovery program and require a very low dose (8 mg or less) of buprenorphine. Headwinds for Probuphine s wider use include the procedures required to insert and remove the rods, the product s high cost ($4,000 to $6,000 for six months) compared with daily buprenorphine ($4,000 to $5,000 per year) and methadone ($2,600 to $5,200), and reimbursement challenges. CAM2038 and RBP-6000 are expected to have more success than Probuphine because they are weekly or monthly injections, offer higher doses of buprenorphine, and require that patients return to their physicians for counseling and to be tested for compliance. Unclear reimbursement rules between states have led to many private clinics accepting only cash. Patients then request reimbursement from their health insurance provider. Treatment preauthorization is often required, but some sources said this requirement is easing. The ACA s possible demise is a concern in the battle against opioid addiction. Key Silo Findings - All 10 said higher patient caps as well PAs and NPs ability to prescribe will increase access to MAT in 3 to 5 years. - Probuphine is another tool in the MAT area, but adoption will be limited. o 7 said Probuphine will serve a niche or subset market of stable patients. o 1 said 20% of her patients are appropriate for Probuphine. o 1 said 80% of his patients could benefit if Probuphine were approved for treatment of chronic pain. o 1 simply acknowledged that the clinic s physician was certified to prescribe Probuphine. - Long-acting injectable buprenorphine is of high interest and expected to serve a wide market if and when approved. o 8 said weekly or monthly injectable buprenorphine will be successful if priced competitively. o 2 did not comment. - Alkermes plc s (ALKS) Vivitrol injectable is considered another effective MAT tool. o 3 who prescribe Vivitrol said getting preauthorization is a challenge. o 2 said the use of Vivitrol is increasing. o 1 said Vivitrol is the most viable treatment, and patients are asking for it. o 1 does not prescribe it because it does not control patient craving. o o 1 is considering prescribing Vivitrol. 1 has not experienced any addition sales activity from the company, but its use may increase in the treatment of alcohol abuse. - MAT pricing: o Daily buprenorphine runs $4,000 to $5,000 per year based on dosage and required physician visits. o Probuphine is $4,000 to $6,000 for 6 months. o Vivitrol is $12,000 to $14,400 per year. 3

4 - Reimbursement varies by state, and insurance companies differ on preauthorization requirements. Generally, buprenorphine is a covered drug. Many private clinics accept only cash or Medicare/Medicaid, and patients then must seek reimbursement from their health insurance providers. Miscellaneous - The possible repeal and replacement of the ACA are of concern to the medical community, which has seen expanded treatment of opioid use disorder because of the current legislation. 1) Physician at a multicenter addiction research and treatment clinic on the West Coast; repeat source The patient cap will moderately affect the market because prescribing physicians must meet the cap criteria. Clinics with multiple medical professionals, including PAs and NPs, will have the benefit of greatly increasing their patient load over time. Probuphine is infrequently used because it is difficult to insert and take out. As a result, it will not affect the buprenorphine market. Braeburn will continue to use Probuphine as a training ground to gain access to physicians for its upcoming weekly and monthly injection, CAM2038. This drug, expected on the market within the year, is widely anticipated. Indivior s long-acting buprenorphine, RBP-6000, also is expected to do well. Alkermes Vivitrol is a deep muscular injection; it may be used more now for alcohol dependency. Overall, opioid prescription dependency is waning. April 8, 2016, interview: The weekly and monthly injectables still were in the early stages of clinical trials, but they had the potential of being very useful and of changing the market. The weekly dose might be best for the unstable patient needing close follow-up. The implantable six-month rods just received advisory committee approval. The source stressed the importance of companies correctly introducing and targeting their drug, especially Braeburn, which did not have opioid treatment experience. Braeburn had started company training. More opioid treatments have failed than succeeded on the market because physicians have not been comfortable with how they were used. The patient cap increase will affect the market moderately at the most. It will take physicians some time to meet the cap limitations requirements. Most buprenorphine is provided by a select group of physicians, so having more slots will be useful. For some doctors who are at their limit, increasing the cap will be absolutely essential to have more slots, and 275 is a lot of slots. That should be plenty for most physicians. If a clinic has multiple physicians, then they get 275 for each physician and 30 for each physician assistant or nurse practitioner. If they have two physicians, then they get 550 total. That is a good number. You could imagine a 700- or 800-person clinic right now. Some buprenorphine is provided through methadone clinics and clinic-like settings, where it is actually not counted against the physician s cap or it s not clear [at this time] that it is counted against the cap. It is hard to know how this will affect the methadone clinics. The methadone clinics have a lot of competing pressures right now with giving methadone and benzodiazepine simultaneously. The ACA supported a ton of methadone, like 20%, and no one knows what will happen with the ACA. Methadone clinics are not ideally positioned, and it is a challenging time for these clinics. Even though there may be technically more reimbursement for opioid dependency, they face criticism if they have a patient on benzodiazepines, and they face loss of income with ACA changes. And the clinics rely on a very inexpensive work force; the counselors are getting paid miserably in these programs. There is a lot of pressure on methadone clinics right now. Methadone clinics aren t really the right business model for doing buprenorphine. It s a different clientele. All the patients want buprenorphine because it is take-home. The people on methadone need stabilization. Methadone clinics are outpatient intensive-care units. I don t think the rods will affect the market; there will be few patients who will benefit from the rods. I don t know any patients who have gotten a rod yet. And I m not sure many people will get one. They are medium-to-difficult to put in; it s up to a 30-minute procedure to put them in because you have to put five of them in. They are pretty hard to take out. It takes a significant effort to remove them, 35 to 45 minutes. The rods become soft and twisty like spaghetti under the skin, and you have to have a special instrument to take them out. And they can break. At the very least, it s a 15- to 20-minute procedure to put them in and a 30-minute procedure to take them out. 4

5 The best market for the rods is some place where there is very little access to opioid treatments, such as Russia or another country where there is little access to help. To do this procedure, you need to have access to a place to do an operation. I m an internist, and internist offices aren t set up for this. Psychiatrists can t do this. You need to do this in a hospital or a come-and-go unit. If I were serious about doing this, I d partner with a plastic surgeon, who could actually put the rods in and take them out. Everyone who puts these rods in must be trained. Braeburn has other reasons for keeping the rod alive: The company has something else up its sleeve that will affect the market and be a complete success, and this is the CAM2038. Right now they are learning how to train people [with the rods], and they are growing and maintaining their buprenorphine relations and the [resultant] interest in a new and improved version. CAM2038 is going to be a killer. This is a once-a-week and a once-a-month formulation, and it works. They ve enrolled their trial, and they are going to the FDA. This is exciting. It s a good bet that it will be out within a year. The future looks brightest for the CAM2038 and possibly for the Indivior long-acting buprenorphine product [RBP-6000]. The future is probably most cloudy for the methadone clinics. The office-based clinics are probably more stable right now than methadone clinics. I ve used quite a bit of Vivitrol. It is a big injection, and you have to give it deep into a muscle. It is not as easy as a flu shot. You don t get any withdrawal when you stop it, so adherence is still an issue. [If usage is increasing, it may be due to] alcohol use. No one has come around our office to promote it. The future looks brightest for the CAM2038 and possibly for the Indivior long-acting buprenorphine product [RBP- 6000]. The future is probably most cloudy for the methadone clinics. The office-based clinics are probably more stable right now than methadone clinics. Physician Multicenter Addiction Research and Treatment Clinic, West Coast Buprenorphine reimbursement varies. Some pay for it, but they have different hoops. They all make you jump through some type of hoops. Some of them still demand that you have a paper or detox plan, which is ridiculous. There s a lot of controversy going on about these drugs, such as benzodiazepines. The methadone clinics are covered much easier than everyone, at least for now. Miscellaneous The prescription opioid epidemic is waning. The back of it has been broken. The next challenge will be drugs like fentanyl or fentanyl-laced heroin. They are being smuggled. They are synthetic, so they don t require fields to grow in; you can make them in a laboratory. Fentanyl will become the primary drug of abuse and greed. 2) Pain management/addiction physician and pharmaceutical consultant in the central United States; repeat source Upping the patient cap will increase the buprenorphine market for three years, and then it will stabilize. Physicians must simultaneously treat the general population, so the biggest problem is the number of physicians available to take on more patients. Allowing PAs and NPs to do some prescribing will help. However, it remains to be seen how the current administration will view funding for new clinics and treatments. The rods are designed for a small subset of the population and are not expected to affect the market very much. Technical challenges with the rods will hinder adoption. The use of Vivitrol has been increasing because the drug is beneficial for both alcohol and opioid addictions, but the drug s high price will prevent it from overtaking the buprenorphine market. April 8, 2016, interview: Widespread usage would depend on the FDA marketing the product as a protection mechanism and as a way for physicians to treat patients without overloading their schedules. The DATA 2000 s patient load changes could make the buprenorphine market robust in five years. Roadblocks included cost and patient selection. Monthly buprenorphine would become more widely adopted than either weekly or six-month dosages, but daily buprenorphine would continue to dominate the market. Monthly dosages allow the physician to monitor the patient and to be paid for those face-to-face visits. Insurers were more likely to pay for long-lasting buprenorphine because it pushes more users into treatment and involves fewer office visits. Insurers seldom bother collecting on unpaid bills for addiction treatment. 5

6 Upping the patient cap will increase the market. The market will benefit, and we will see a steady increase in buprenorphine usage over time. But in three years it will be about as good as it will get for a while. The bigger problem is the number of providers; this will make the biggest difference. The most important piece of the legislation is allowing physician assistants and nurse practitioners to do the prescribing. The majority of physicians have never hit 100 patients. Most physicians see other patients as well. If you are in primary care, you would maybe see 60 buprenorphine patients because you also take care of other types of patients. So in the progression of things, it will be a while before the numbers bump up. A lot of how this plays out depends on the current administration. I don t believe they will be enthusiastic about the treatment paradigm. Will they be open to new clinics? This may be limited. Our state legislature is considering using $1 million of cannabis-derived tax revenue to fund opioid medical management. There was also new federal money to support new clinics, but all bets may be off. Here, methadone clinics are becoming more involved with buprenorphine. The methadone clinics are not affected by a patient cap because the environment is more controlled. Opioid treatment programs are set up to do daily observed medication administration. This has built-in safety because it limits the amount of methadone and buprenorphine out in the community, where it could be diverted and/or overused. The rods will have a greater impact on those patients who are well along into recovery. It is not for a lot of patients. The rods won t do for early patients; I wouldn t recommend them. Once the rods are removed, you would still have to taper down on buprenorphine delivered in the mouth. Opioid addiction is a chronic disease. Maybe only 15% to 20% of the patients can transition off buprenorphine in nine to 12 months. These patients need to be comfortable in recovery. Overall, only patients on a lower dose of buprenorphine can use the rods. The rods deliver the equivalent of 8 mg per day, but most patients are on 12 to 16 mg per day of buprenorphine given in the mouth by buccal or sublingual route. The other factor is that physicians want to see their patients on a monthly basis for evaluation, but there will be a significant number of those placed on six-month rods who simply won t come in monthly. The business of these drugs lies within the criminal justice domain, but an amount is put into play in general practice. Usage of Vivitrol is increasing, as it should be. It is my No. 1 go-to now for co-occurring opioid and alcohol addiction, and we will see more data on it in the future. Vivitrol is very effective for alcohol and opioids, and some patients need to Upping the patient cap will increase the market. The market will benefit, and we will see a steady increase in buprenorphine usage over time. But in three years it will be about as good as it will get for a while. Pain management/addiction physician Pharmaceutical consultant Central U.S. be treated for both. What you don t hear is what it can do off-label, and these side issues are important. There is some data on Vivitrol for treating gambling, sex and methamphetamine addictions. This information has not been presented to the FDA, and the drug is not approved for these usages. There is some data on buprenorphine, not head-to-head data, that show a favorable response for cocaine and alcohol addiction, but not tobacco addiction. I consult for Indivior, and they have been very quiet, closed-mouthed about RBP-6000, so I couldn t address that. I expect the company thinks it may be better than CAM2038, which I read about the other day. Other treatment options are stacking up nicely, and market success will be based on performance. Doctors will want monthly delivery because they want to see their patients on a monthly basis most of the time. We will have to see how this all caps out. Vivitrol is extremely expensive, at least $1,000 per month; it used to be $750 per month. It is covered by Medicare. But the high price will prevent Vivitrol from surpassing buprenorphine usage, which easily runs $600 to $800 monthly. Insurers support these drugs although I m not sure how well. But this is an environment that is very concerned about opioid overdose deaths, so it is expected that treatment options should do well going forward, for a while in any case. The insurers support procedures more than they do office visits. 6

7 Miscellaneous We are starting to see more nonbranded information being delivered in continuing medical education events due to the opioid overdose death picture. This is resulting in the delivery of more information about Vivitrol, for example, because the company to date has been more focused on promoting its use in the criminal justice system. Frankly, most office-based practices have heard very little about it. The pharma companies are now giving compensation to speakers physicians, physician assistants and nurse practitioners to get the information out. 3) Addiction and university clinical research physician who prescribes Probuphine on the West Coast Changing the patient cap will take time. A higher patient cap will help those centers with waiting lists and make it easier to accept third-party reimbursement. However, not all centers can accommodate more patients. The implants have a niche role and will rise slowly in use. Insertion and extraction are not necessarily challenging. Some centers have many patients who are appropriate for the rods, but various logistics limit them as candidates. Other roadblocks include the additional training required, higher costs, lack of patient and clinician knowledge, and difficulties with billing, payment and shipping. Vivitrol is on the rise because it is easy to use, and physicians are now embracing MAT. [Upping the patient cap,] especially in markets with waiting lists, should help. This may also make it easier for doctors to accept third-party payer reimbursement for care with buprenorphine, which was limited with the caps. This change should be happening now. [Our resident care center] is small 12 beds, so the patient cap will have no effect on us. Physician assistants and nurse practitioners will be allowed to prescribe opioid therapies, but the pathway isn t available yet. Therapists cannot prescribe medications. I see the implant as having a niche role that will grow over time. I have done about four patients in the past year. Probuphine is indicated for stable patients on 8 mg or less of buprenorphine. [The percentage of] patients appropriate for the implant depends on the individual, their preference and their availability. Many of the patients we see are candidates for the rods, but logistic issues limit their choices. It takes me five to 10 minutes to insert the rods and 20 to 30 minutes to remove them. Probuphine [roadblocks] are the additional training required, higher costs, and lack of patient and clinician knowledge. I see [Probuphine] as having a niche role that will grow over time. I have done about four patients in the past year. Addiction and university clinical research physician who prescribes Probuphine, West Coast There are also logistic issues with getting the implants. Billing, payment and shipping were a little rough at first, but my office person finally figured it out. Vivitrol is on the rise. More and more doctors are starting to embrace MAT, and Vivitrol is easy to use. It just doesn t have a very robust effect. Vivitrol costs $1,000 per month, but no one pays that. Either their insurance pays, or they don t use it. Braeburn s next product sounds great, but it is still in the pipeline. Directly observed therapies have the potential to reduce risk of diversion and ensure compliance. This may well be very appealing to clinicians and third-party payers. Prior authorization is often required, and reimbursement is plan-specific. 4) Research physician at a multicenter addiction treatment clinic in the Midwest; repeat source The increased patient cap and the use of Probuphine will allow more practices to offer complete treatment services. The number of patients using Probuphine should increase within the year, but this will depend on the possible repeal of the ACA, which currently insures many from the clinic s base of more than 9,600 annual patients. Twenty percent of patients 7

8 are appropriate for the implantable rods; 60% are on daily medication; and 100 of this source s patients are on Vivitrol. More patients ask for Vivitrol than buprenorphine or methadone. April 8, 2016, interview: Long-term treatments would benefit anyone addicted to opioids as long as the medication was coupled with counseling and urine testing. The pace of adoption would vary depending on the required physician training. Weekly or monthly implantable buprenorphine would not be well received because the procedure was too invasive for that length of time. However, six-month implantable rods would be widely adopted. The price of a six-month rod should be comparable to six months of oral medication, and insurers and able patients alike would pay the cost. The source also expected an intermediate range (one- to two-week) treatment to become available. The increase from 100 to 275 patients will push more practices to offer complete treatment services such as counseling in one building. Our treatment center now has all physicians with waivers at 275. The long-acting medications will expand the availability of treatment since providers will be less worried about diversion. It is hard to say how long for the implant market to grow; hopefully within the year, numbers will increase. I was on the last phase trial for the FDA, and it took a long time getting finally approval. Probuphine has only been approved by one Medicaid provider in Ohio, which may collapse if the Affordable Care Act is repealed. Twenty percent of our current patients are appropriate for implants; 60% for daily, 10% for weekly, and 10% for monthly. The rods are technically challenging if you haven t sutured in a while. The physician must have done a surgical procedure in the last year sutures, incision and drainage, etc. I have done training for rod implantation over the last summer to several hundred physicians. Those who have some surgical skill are fine, psychiatrists not at all. I found NPs and PAs to be the most proficient, and they will be great implanters and removers. NPs and PAs can already do implants and removals if they take the training. I personally certified five here in our state. They can t write the script for the rods, however, because they don t have a DATA waiver yet in our state. They will be allowed to get a waiver and prescribe [Indivior s] Suboxone sometime this year. Reimbursement for the procedure is the biggest hurdle, followed by facility-appropriate space and trained implanters. Vivitrol is the most viable treatment I see as a provider. I have over 100 patients on Vivitrol, and they do very well and transition off easily. As long as the ACA pays for the injection, I see more and more patients on it. I have more patients asking for Vivitrol now than methadone or buprenorphine. The only other price point I know is Vivitrol, which is $890 wholesale and $1,200 retail in my locale. Twenty percent of our current patients are appropriate for implants; 60% for daily, 10% for weekly, and 10% for monthly. Research physician Multicenter addiction treatment clinic Midwest I have grave concerns for my patient base, who are people at or below poverty level getting any type of medicationassisted treatment, if the ACA is repealed. Our governor chose not to expand Medicaid and has no plans to do so even if the ACA is repealed. I think a lot of people will lose access and once more be lost. They are homeless or have transitory housing, making them ineligible to vote and, therefore, voiceless in our society. Our opioid treatment program uses methadone, buprenorphine and Vivitrol. Methadone and buprenorphine are dispensed and included in daily rate billed to Medicaid, if the patient has that. We are community-funded, so the rest of the patients are treated using those funds. We must get prior authorization for all Vivitrol injections, and it has been pretty easy. But I see that changing a great deal if the ACA is repealed. 5) Psychiatrist and founder of two psychiatric treatment centers on the East Coast MAT for opioid addiction was added to this source s psychiatric centers about a year ago. The centers have experienced slow and steady patient growth and now serve approximately 45 patients using daily Suboxone. The expanded opioid treatment cap is a good step in the fight against the epidemic, but it will not mean large numbers of additional patients 8

9 can be added overnight. The process takes time and requires certification and preparation to meet the needs of more patients. This source said he will seek certification to expand when his practices reach the 100-patient threshold. He does not use Probuphine, and said implanting and removing the rods may be difficult. He is very interested in the longacting injectables. The expanded treatment cap is a good thing for fighting the opioid addiction epidemic, but it s not a quick fix. Overall, the rule changes will increase the number of patients that get treatment, but it will be slow process. It takes time to implement and prepare to service these patients. I added Suboxone treatment a year ago at my centers, and we have grown at a slow and steady pace to 45 patients. I do plan to seek the expanded cap when we reach the 100-patient threshold. The rule change to allow PAs and NPs to be directly involved with treatment will be very helpful in combating the epidemic. There is a great need for more treatment options. I do think long-acting buprenorphine will lead to better retention of patients and possibly better efficacy. But the rods are really only for patients that already doing well with their recovery effort, and that is not a large number. I do not prescribe Probuphine now. However, I will consider it if it is not too difficult to implant. If it requires making an incision and stitching, I may not want to get involved. I am very interested in the week- and month-long injectable. I think it will be easier than the rods. I don t use Vivitrol, but it has come up in some of our staff discussions and we may start using it. It could be a good alternative for some of our patients. The expanded treatment cap is a good thing for fighting the opioid addiction epidemic, but it s not a quick fix. Psychiatrist Founder of 2 treatment centers East Coast I only accept Medicare, and I have not had any problem with reimbursement for treating patients with Suboxone. Patients that private pay and submit for reimbursement from their insurance providers have not had any problems. Preauthorization is required by some insurers and not by others, and it s not a big deal to get. Miscellaneous We are in the early phase of mobilizing a medical and societal response to a huge, unmet need of treating opioidaddicted people that want to stop using. It is going to take some time. 6) Physician who is board-certified in addiction medicine With a 275-patient cap, this physician can maintain patients on Suboxone longer, which helps prevent relapses. He advocates use of affordable, long-acting buprenorphine for chronic pain. He also cited a large market for addiction treatment using buprenorphine, especially if patients are educated about how it will control their pain. Vivitrol works quite well in helping patients stay off opioids, but insurance companies have been requiring preauthorization. Also, it is available only from a few specialty pharmacies, which can create delays in receiving the medication. I m capped at 275, so I do have that. When I was just capped at 100, I d take people off the Suboxone faster than I normally would because I d want new patients. So as soon as I could get somebody off Suboxone, then I could add another patient. So if I have a number of 275, I can keep patients on longer. After seriously thinking about this for a long time, I realized that some of these people are going to be on it like their insulin for the rest of their lives. I use a lot of buprenorphine for chronic pain. And I want people to be able to have buprenorphine for chronic pain for the rest of their lives because if they have a back injury [as an example] and they stay on buprenorphine, then they never get back on heroin or heavy-duty opioids again. We need to make some big change in the statute. There shouldn t be limits on the number of people we put on buprenorphine. Currently, I d say 80% of my patients in my pain clinic are on buprenorphine for chronic pain. 9

10 [In this state] Medicaid will only pay for buprenorphine for three years for a Medicaid patient. They won t pay for any Suboxone or buprenorphine unless it s for addiction. It s really sad because I ve had all these patients who have been on buprenorphine once a day for three years. They have a good job and they are doing well, and then the insurance won t pay for it so they have to pay it out of their pocket or risk coming off it and going on another opioid. My nurse practitioner is getting approved [to provide the addiction treatment using buprenorphine]. The [change in the law won t be] implemented until March or April of this year. There are still a lot of people buying things off the street illegally. There s a big market [for opioid addiction treatment using buprenorphine]. A lot of people will come in to get it, especially if [providers] do good education with it on how it s going to keep them off opioids and it s going to control their pain. It s the legal thing to do to help them. Probuphine is out, and I got trained on that. But the trouble is, who is going to pay $5,000 to 6,000 [upfront] every six months to get it put in? You re only supposed to be able to do it for two cycles, which would be one year. I haven t had one insurance approve it. When I got trained a few months ago, it was [expected to last for] about four to six months depending on the patient and how they metabolize it. It only takes me 10 to 15 minutes to put it in, and it still costs about $5,000. If the company was smart, they d get [long-acting] buprenorphine approved for chronic pain. Can you imagine me putting that into somebody with chronic pain? It d be worth $5,000 to put in those sticks. Can you imagine six months without pain? If you didn t have to put patients under the 275 [cap], I d say most of my patients would go to long-acting. The patch works well for once a week, but if I could have one that goes for four to six months if it was reasonably priced, 80% [of my patients] would switch over because those things under your tongue don t taste good, and it s hard to remember them every day, and then they get stolen. There are so many variables with it. I used tons of methadone for chronic pain because I d dose it three times a day and it doesn t confuse your mind and it gets rid of your pain. But the way methadone clinics are run, they give people a whopping dose at 6 a.m. They have to be there early, and it only lasts in their bodies three to four hours before it starts deteriorating, and then they go into withdrawal until the next morning. The [clinics] never seem to taper the dose for these patients. It s the worst moneymaker in the whole country because you have all these poor addicts who are going there every day and spending their $50 to $100 a week to their get methadone, and it s making them want more and more methadone because they only give them one [big] dose a day in the morning. Methadone is also an NMDA receptor blocker, so it s better for back pain There are still a lot of people buying things off the street illegally. There s a big market [for opioid addiction treatment using buprenorphine]. A lot of people will come in to get it, especially if [providers] do good education with it on how it s going to keep them off opioids and it s going to control their pain. Physician Board-certified in addiction medicine and bone pain than any pill on the market. And it s dirt cheap. I can buy a bottle of 100 methadone for, like, $20 to $30. These methadone clinics are a joke. I love Vivitrol. What I used to do is if the patients wanted to get off heroin, let s say, we d put them on Suboxone for three weeks and just taper really quickly, and then we d wait 24 hours to give them a shot of Vivitrol. And I had great success with that. Once patients came off opioids, for the next three to six months they really do well on Vivitrol. Insurers started to throw up these roadblocks. They want preauthorization for it, and it s $1,200 [for a Vivitrol shot a month] if you don t have preauthorization for it. Then you have to get it from only a couple of specialty pharmacies in the country. You just get paid for a regular office visit [for buprenorphine addiction treatment]. The office visit can take 15 to 20 minutes, but some of these Suboxone clinics... will get a couple of doctors and pay them $100 to $200 an hour and then try to make [the patients] pay $100 to $125 in cash for a [10-minute] visit. And then they have to come in every week or two weeks to get their Suboxone prescription. It s becoming a real moneymaker for some of the business men. My daily [insurance] rates for inpatient and outpatient [addiction treatment] have been cut 75% in the last year.... The government and the agencies say they want to help all these addicts, but nobody on the other end of the payer 10

11 scale is paying for it. Then they make the prices high for the drugs, and you see why these poor kids go back on heroin. It s because there s nobody out there to help them the insurances or the drug companies. Nobody is using [Depomed Inc. s/depo] Nucynta [for pain]. I haven t seen a script for Nucynta anywhere for a year. 7) Owner of an outpatient medication-assisted treatment program The 275 cap will increase patient volume but also will make the market more competitive. The clinic plans to use the monthly injection once available. The program does point-of-care urine drug testing at each visit and refers repeatedly noncompliant patients to a more advanced level of care. [The increase in the cap will] obviously make it more competitive for clinics to get patients, and at the same time it s going to allow us to increase our business. We only have one doctor, and that doctor is bumped up against 100 and waiting until he s eligible to increase it to 275. That will allow us to add 175 patients to our clinic, which is a good thing, but at the same time we are having to do more things to attract patients, like more advertising. We are in the process of having a nurse practitioner get certified [to provide buprenorphine treatment]. [The cap for NPs and PAs] is 30 for their first year, and after the first year they can go up to 100. No, it is not 275. I don t think it s ever going to go to 275. As more patients become aware of treatment, hopefully more will seek treatment. I think the fact that the media covers the opioid epidemic is helpful. I can t predict how many patients are going to be seeking treatment. That really depends, and it varies day to day depending on what is on the street, what the opioid overdose death rate is. Some weeks we get a lot of calls, and some we get very few calls. We prescribe buprenorphine products. One of them is Suboxone. We also prescribe generic products. There is one long-acting product; it s the implantable device. Our doctor is qualified to do that procedure. We are very interested in the long-acting [injectable buprenorphine] products. It s something we will do once it becomes available. It s not available yet. Just the implantable device is available. There s a Vivitrol monthly injection that s available, but that s not a long-acting buprenorphine product. We are taking new patients, and we don t get flooded with patients. We get a steady stream of new patients, anywhere from three to five a week. [Long-acting buprenorphine] will help with diversion. With less of the medication out on the street, I think that would be helpful. It may also push more patients into treatment because they can t get it. They can get less of it. This is a continuum. This is not a sprint. As long as the product is out, it will continue to help the diversion, it will continue to create more treatment for people. There s no set time. It will be ongoing. Patients do find it hard to get off of [buprenorphine], unfortunately.... Most patients come off it because they are relapsing, not because they are weaning off of it. [Once the long-acting injections become available] when our stable patients come in for their monthly appointment with our doctor, we will be doing an injection instead of giving them a monthly prescription. They won t be taking a daily medication. They will just get an injection, and they will forget about it pretty much. I would say maybe 40% [would be candidates for the monthly injection]. We are very interested in the long-acting [injectable buprenorphine] products. It s something we will do once it becomes available. It s not available yet. Just the implantable device is available. Owner Outpatient MAT program For the implantable, I think that s $4,000 or $5,000. We haven t done one, but I have heard insurers are covering it so there s no out-of-pocket cost to the patient. Vivitrol is a blocker. We don t use it at the moment because our concern is that it doesn t take care of the patient s craving. It s a pretty specific medication for a specific patient type. We haven t had any candidates for it yet. [That would be] someone who has a short history of opioid addiction coming out of a rehab, because you need to have no opioids in your system to do it. Most of our patients do have opioids in their system. 11

12 Suboxone is about $16 a day, I would say, but the patients insurances almost always cover the medication. We have very few patients who have to pay out of pocket for their medication. [Payers require preauthorization for the medication] about half the time. We do not accept insurance for the office visit. The patient has to pay out of pocket. I don t know what the commercial insurance rate is [for office visits], but it varies widely from company to company. 8) Addiction psychiatrist involved in national policy decision-making, teaching and clinical care The federal rule changes ideally will triple the number of people receiving treatment with buprenorphine. Success will hinge on whether patients find the system to be simple enough to use. Probuphine will not have a large market because the dosing may be lower than what patients are taking orally. Also, it is costly and involves a six-month commitment. [The change in the treatment cap] will help. I think some people in certain geographical areas are overloaded; they are sort of maxed out at 100, and it will allow them to increase it. I do think there are a number of MDs who are reluctant to use their license, their waiver, so those folks are still going to resist it. With the new 21 st Century Cures Act, we are going to see some training of doctors state by state. That might also increase the prescribing capability, and the total number of slots for treatment would expand. In the ideal world, maybe [the MDs, NPs and PAs] will triple the number of folks suffering from addiction who get treated. There are going to be a number of people maybe half the people who have addiction who won t want to get treatment, and there may be this invisible barrier that we don t understand because we haven t had enough treatment to give there. We might be able to get 50% of the people some kind of treatment, but I suspect the people themselves will balk at treatment. If we have 15% to 20% of people who get treatment now and that triples, then we are kind of up to the 50% to 60% range. That would be seriously helpful if that happened. I think [it would take] a couple of years. This is going to depend on government, Medicaid and things like that. The addicts are going to have to see and experience a simple way of getting into treatment. The more preauthorization rules and when it stops [being simple] they are just going to roll their eyes [and say], All they really want is my money; they don t want to help. We are now talking about a complicated medical system that has its own rules, and a political system that has totally different rules, and we have state politics vs. federal politics. If those three systems can coordinate... and you have a centralized community or regional intake system, then you might actually see the improvement pretty quickly. Part of the ambivalence about PAs and NPs [providing the addiction treatment] is they aren t trained as well as doctors. The PAs and the NPs can get their buprenorphine waiver, but they have to do 24 hours of education. The MDs only had to do eight hours of education originally, so maybe the PAs and the NPs will get more appropriate addiction and chronic pain training that would allow them to do a better job. Frankly, I don t think there is going to be a big market [for the long-acting implantable rods] because they can require a six-month commitment [and] because the dose that s given may not be as big as the dose that you get Some people in certain geographical areas are overloaded; they are sort of maxed out at 100, and it will allow them to increase it. I do think there are a number of MDs who are reluctant to use their license, their waiver, so those folks are still going to resist it. Addiction psychiatrist involved in policy decision-making, teaching and clinical care orally. That s going to depend on the setting. [I]t may be that in the criminal justice system, people might get something started right before they leave jail that will continue to keep them in a nonvulnerable position. If somebody is in a rural setting and the [practice is] the dominant location, they might hold that out [as an option]. I don t see it as taking over the market. It s fairly pricey somebody has to pay for it.... I think that is going to be a challenge, and I think it will stumble along. Depending on the dosing, [long-acting monthly injections] might work well..... The injection may not be quite so popular because people don t like getting stuck with needles. 12